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The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation for Deep Sedation Fiberoptic Bronchoscopy

The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation Reduce the Incidence of Hypoxia in Patients Undergoing Sedated Fiberoptic Bronchoscopy.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07389083
Enrollment
50
Registered
2026-02-05
Start date
2025-12-28
Completion date
2026-03-30
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia, Pulmonary Infection, Pulmonary Nodule

Keywords

fiberoptic bronchoscopy, Hypoxia, Deep sedation, supine position, tongue-base fallback, supraglottic oxygenation

Brief summary

Bronchoscopy is now widely used for the diagnosis and treatment of various respiratory diseases. However, the procedure is highly stimulating and provokes a strong stress response; because the airway is shared, patients are prone to hypoxia. With the growing emphasis on comfortable care, demand for anesthesia during bronchoscopy has increased. Deep sedation is the most common approach, but when administered in the supine position it often causes the tongue base to fall back. Both nasopharyngeal and oropharyngeal airways can relieve this obstruction, yet neither connects seamlessly to an oxygen supply line, resulting in insufficient oxygen delivery.We therefore replaced the nasopharyngeal airway with a wired endotracheal tube (size 4.0 or 4.5) inserted via the nose. This thinner tube couples easily to an oxygen line or ventilator circuit, partially relieves airway obstruction, and allows ample supraglottic oxygenation. The present study was designed to evaluate the feasibility and safety of this modified oxygen-delivery method in patients undergoing deep sedation for bronchoscopy.

Interventions

DEVICEwire-reinforced tracheal tube

Supraglottic oxygen therapy delivered via wire-reinforced nasotracheal tube

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Undergoing fiberoptic bronchoscopy under deep sedation. * Written informed consent obtained from the patient or their legal representative. * Clear understanding of, and voluntary participation in, the study, with informed-consent form signed by the patient or their legal representative.

Exclusion criteria

* Age \< 18 years * BMI \> 30 kg/m² * Previous history of abnormal recovery from anesthesia/surgery * History of recurrent epistaxis, nasal bone fracture, nasal polyps, or sinus surgery * Chronic use of opioid analgesics, benzodiazepine hypnotics, or antidepressant medications * Known allergy to any of the anesthetic agents employed * Anticipated difficult airway * Increased intracranial pressure * Active upper-respiratory-tract infection of the oral, nasal, or pharyngeal regions * Severe cardiac insufficiency (functional capacity \< 4 METs) * Severe renal failure requiring dialysis prior to surgery * Pre-operative oxygen saturation on room air \< 92 % * Any condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this trial

Design outcomes

Primary

MeasureTime frame
The incidence of hypoxia(75% ≤ SpO2 < 90% for <60 s)Periprocedural

Secondary

MeasureTime frame
The incidence of sub-clinical respiratory depression(90% ≤ SpO2 < 95%)Periprocedural
The incidence of severe hypoxia(SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s)Periprocedural

Countries

China

Contacts

CONTACTYueying Zheng
1507128@zju.edu.cn+8613777408863
CONTACTYeke Zhu
21618018@zju.edu.cn+8613515815457

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026